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Drug

Asenapine maleate

Approved · EMA
Emerging researchLate-stage developmentRising momentum

Also known as Asenapine, Saphris.

RxNorm860647
5
Research papers
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Multicenter, Randomized, Double-blind, Fixed-dose, 6-week Trial of the Efficacy and Safety of Asenapine Compared With Placebo in Subjects With an Acute Exacerbation of Schizophrenia (Phase 3)

Clinical trial2024-06-20Results posted · ClinicalTrials.gov

Efficacy and Safety of 3-Week Fixed-Dose Asenapine Treatment in Pediatric Acute Manic or Mixed Episodes Associated With Bipolar I Disorder (Protocol No. P06107)

Clinical trial2024-06-20Results posted · ClinicalTrials.gov

A Multicenter, Randomized, Double-Blind, Fixed-Dose, 6-Week Trial of the Efficacy and Safety of Asenapine Compared With Placebo Using Olanzapine as an Active Control in Subjects With an Acute Exacerbation of Schizophrenia

Clinical trial2024-06-18Results posted · ClinicalTrials.gov

A Phase 3b, Multicenter, Double-Blind, Fixed-Dose, Parallel-Group, Three Week Placebo Controlled Trial Evaluating the Safety and Efficacy of Asenapine in Subjects With Bipolar 1 Disorder Experiencing an Acute Manic or Mixed Episode (Protocol P05691 [Formerly 041044])

Clinical trial2024-06-18Results posted · ClinicalTrials.gov

Long-term Extension Trial of Asenapine in Subjects With Schizophrenia (Phase 3 ; Protocol No. P06125)

Clinical trial2024-05-28Results posted · ClinicalTrials.gov

Long-term Study of Asenapine in Subjects With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (Protocol P06238)

Clinical trial2024-05-28Results posted · ClinicalTrials.gov

A Sequential Groups, Open Label, Rising Multiple Dose Study to Assess the Pharmacokinetics, Safety and Tolerability of Sublingual Asenapine in a Pediatric Population With Schizophrenia or Bipolar I Disorder

Clinical trial2024-05-23Results posted · ClinicalTrials.gov

Asenapine for the Acute Treatment of Pediatric Manic or Mixed Episode of Bipolar I Disorder.

Research2015-10-24Journal of the American Academy of Child and Adolescent Psychiatry

Asenapine: Efficacy and safety of 5 and 10mg bid in a 3-week, randomized, double-blind, placebo-controlled trial in adults with a manic or mixed episode associated with bipolar I disorder.

Research2015-09-25Journal of affective disorders

Safety and Efficacy from an 8 Week Double-Blind Trial and a 26 Week Open-Label Extension of Asenapine in Adolescents with Schizophrenia.

Research2015-06-01Journal of child and adolescent psychopharmacology

Asenapine as adjunctive treatment for acute mania associated with bipolar disorder: results of a 12-week core study and 40-week extension.

Research2012-02-01Journal of clinical psychopharmacology

Approval: Sycrest (EMA)

Regulatory2010-09-01EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Asenapine maleate
Aliases & brands
AsenapineSaphris
RxNorm CUI
860647
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2010-09-01
Latest approval
2010-09-01
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2010-09-01Approval
Approval: Sycrest (EMA)

Indication: Sycrest is indicated for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

38 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
38
registered trials across all phases
LATEST COMPLETION 2015
35
Late-stage (III+)
35
Completed
3
Discontinued
PHASE DISTRIBUTIONn = 38
Phase 12Phase 21Phase 331Phase 44

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

An Open-label Switch Study to Asenapine in the Early Stage of Psychosis

Unknown statusPH IVCentre de Recherche de l'Institut Universitaire en Santé Mentale de Québecn=122014

Asenapine in the Treatment of Older Adults With Bipolar Disorder

CompletedPH IVUniversity Hospitals Cleveland Medical Centern=152014

A Randomized Comparison of Twice-Daily Versus Once-Daily Asenapine for Schizophrenia

CompletedPH IVDuke Universityn=302013

Treating Acutely Agitated Patients With Asenapine Sublingual Tablets: A Single-Dose, Randomized, Double-Blind Placebo Controlled Trial

CompletedPH IVUnity Health Toronton=1202012

A Double-Blind, Placebo-Controlled Trial of Asenapine in the Prevention of Recurrence of a Mood Episode After Stabilization of an Acute Manic/Mixed Episode in Subjects With Bipolar 1 Disorder (Phase 3B, Protocol P06384)

CompletedPH IIIForest Laboratoriesn=5612015

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Double-Blind, Placebo-Controlled Trial of Asenapine in the Prevention of Recurrence of a Mood Episode After Stabilization of an Acute Manic/Mixed Episode in Subjects With Bipolar 1 Disorder (Phase 3B, Protocol P06384)

CompletedPH IIIForest Laboratoriesn=5612015

Long-term Extension Trial of Asenapine in Subjects With Schizophrenia (Phase 3 ; Protocol No. P06125)

CompletedPH IIIOrganon and Con=2012015

A Multicenter, Double-Blind, Fixed-Dose, Long-Term Extension Trial of the Safety of Asenapine Using Olanzapine as an Active Control in Subjects Diagnosed With Schizophrenia Who Completed Protocol P05688

CompletedPH IIIForest Laboratoriesn=1052015

A Multicenter, Double-Blind, Fixed-Dose, Long-Term Extension Trial of the Safety of Asenapine in Subjects Diagnosed With Bipolar 1 Disorder Who Completed Protocol P05691 (Formerly 041044) (Phase3B, Protocol P05692 [Formerly 041045])

CompletedPH IIIForest Laboratoriesn=1652015

A Multicenter, Randomized, Double-Blind, Fixed-Dose, 6-Week Trial of the Efficacy and Safety of Asenapine Compared With Placebo Using Olanzapine as an Active Control in Subjects With an Acute Exacerbation of Schizophrenia

CompletedPH IIIOrganon and Con=3602014

A 50-Week Open-Label, Flexible-Dose Trial of Asenapine Extension Treatment to P06107 in Pediatric Subjects With Acute Manic or Mixed Episodes Associated With Bipolar I Disorder

CompletedPH IIIOrganon and Con=3222014

Research activity

5 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20122016
Most influential

Asenapine as adjunctive treatment for acute mania associated with bipolar disorder: results of a 12-week core study and 40-week extension.

Journal of clinical psychopharmacology · 2012 · 51 cites

Asenapine for the Acute Treatment of Pediatric Manic or Mixed Episode of Bipolar I Disorder.

Journal of the American Academy of Child and Adolescent Psychiatry · 2015 · 38 cites

Safety and Efficacy from an 8 Week Double-Blind Trial and a 26 Week Open-Label Extension of Asenapine in Adolescents with Schizophrenia.

Journal of child and adolescent psychopharmacology · 2015 · 33 cites

Asenapine: Efficacy and safety of 5 and 10mg bid in a 3-week, randomized, double-blind, placebo-controlled trial in adults with a manic or mixed episode associated with bipolar I disorder.

Journal of affective disorders · 2016 · 22 cites

Short-term safety and pharmacokinetic profile of asenapine in older patients with psychosis.

International journal of geriatric psychiatry · 2012 · 15 cites
Recent papers

Asenapine: Efficacy and safety of 5 and 10mg bid in a 3-week, randomized, double-blind, placebo-controlled trial in adults with a manic or mixed episode associated with bipolar I disorder.

Journal of affective disorders · 2016 · 22 cites

Asenapine for the Acute Treatment of Pediatric Manic or Mixed Episode of Bipolar I Disorder.

Journal of the American Academy of Child and Adolescent Psychiatry · 2015 · 38 cites

Safety and Efficacy from an 8 Week Double-Blind Trial and a 26 Week Open-Label Extension of Asenapine in Adolescents with Schizophrenia.

Journal of child and adolescent psychopharmacology · 2015 · 33 cites

Asenapine as adjunctive treatment for acute mania associated with bipolar disorder: results of a 12-week core study and 40-week extension.

Journal of clinical psychopharmacology · 2012 · 51 cites

Short-term safety and pharmacokinetic profile of asenapine in older patients with psychosis.

International journal of geriatric psychiatry · 2012 · 15 cites
Journals, researchers & institutions
Top journals
  • International journal of geriatric psychiatry1
  • Journal of affective disorders1
  • Journal of child and adolescent psychopharmacology1
  • Journal of clinical psychopharmacology1
  • Journal of the American Academy of Child and Adolescent Psychiatry1
Leading researchers
  • Mackle M4
  • Mathews M3
  • Braat S2
  • Findling RL2
  • Hundt C2
  • Landbloom RL2
  • Panagides J2
  • Szegedi A2
Leading institutions
free-text, unnormalised
  • Forest Research Institute (now Actavis)2
  • 1 The Johns Hopkins University/Kennedy Krieger Institute1
  • 5 Forest Research Institute1
  • 6 University of Colorado/Children's Hospital Colorado1
  • Johns Hopkins University and the Kennedy Krieger Institute1
  • Lucille Packard Children's Hospital1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.